PTSD, AUD, and Interpersonal Conflict: Within-person Associations

University of South Dakota

Status: Enrolling

Conditions: Alcoholism; Stress Disorders, Post-Traumatic

Treatments: Behavioral: Alcohol CBM; Behavioral: PTSD CBM; Behavioral: PTSD Sham; Behavioral: Alcohol Sham

Study type: Interventional

Funder types: Other; Other U.S. Federal agency; NIH

Identifiers

NCT04552782

1R01MH122954

Details and patient eligibility

About

The present study seeks to increase understanding of Alcohol Use Disorder (AUD) and Posttraumatic Stress Disorder (PTSD) among veterans, an important public health concern. We will study the effects of regulatory deficits and sleep disturbance on the dynamic course of PTSD and AUD. The study will investigate whether a short, computerized training in the laboratory will alter maladaptive response biases and reduce associations between sleep disturbance, affect and behavioral dysregulation, AUD symptoms, and PTSD symptoms in the real world.

Enrollment: 250 estimated patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• OIF/OEF/OND veterans
• At risk for PTSD (i.e., PCL-5 ≥33) and/or AUD (i.e., AUDIT ≥ 7 (women) ≥ 8 (men))

Exclusion criteria

• Psychosis or severe Alcohol Use Disorder that contraindicates participation (based on interview)
• Active suicidal or homicidal ideation that contraindicates participation (based on interview)
• [exclusion criteria removed 6/2022] - Severe risk for sleep apnea (a positive score in three categories of the Berlin Questionnaire), or reported treatment for sleep apnea

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: Double Blind

---

250 participants in 4 patient groups

Alcohol Cognitive Bias Modification (CBM) + PTSD CBM

Experimental group

Treatment:

Behavioral: PTSD CBM

Behavioral: Alcohol CBM

Alcohol CBM + PTSD Sham

Experimental group

Treatment:

Behavioral: PTSD Sham

Behavioral: Alcohol CBM

Alcohol Sham + PTSD CBM

Experimental group

Treatment:

Behavioral: Alcohol Sham

Behavioral: PTSD CBM

Alcohol Sham + PTSD Sham

Sham Comparator group

Treatment:

Behavioral: PTSD Sham

Behavioral: Alcohol Sham